Multicentre Biomarker Study in CRPC Treated With Enzalutamide

• Status: Recruiting
• Trial end date: 0000-00-00
• Target enrollment: 187
• Participant gender: Male

Summary

Prospective Multi-centre Study of Prognostic Factors in Castration Resistant PROState Cancer Treated With Enzalutamide (PROSENZA).

• Phase: N/A
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Centro Nacional de Investigaciones Oncologicas CARLOS III
• Collaborator: Fundación Pública Andaluza para la Investigación de Málaga en Biomedicina y Salud
• Last Updated: 2016-10-05

Criteria

Inclusion Criteria:

1. Provision of informed consent.

2. Eighteen years of age or older.

3. General health status acceptable and compatible with active treatment: ECOG ≤0-2.

4. Histological confirmation of prostate cancer diagnosis.

5. Prior resistance to biochemical castration with an LHRH agonist (or surgical castration through bilateral orchiectomy) and progression to an anti-androgen drug (e.g. bicalutamide, nilutamide or cyproterone acetate).

6. Biochemical progression upon prior treatment in agreement with PSAWG2 criteria, confirmed by a second PSA test.

7. Castrate levels of testosterone in peripheral blood: testosterone <0.5 ng/ml.

8. Candidates for standard treatment with enzalutamide: 160 mg continue on cycles of 28 days.

9. Availability of anatomopathological tumour material (e.g. a paraffin block of the prostatectomy or initial biopsy of the metastasis).

10. Acceptable hematological, hepatic and renal functions and without contraindications for the administration of abiraterone in agreement with its respective summary of products characteristics.

Exclusion Criteria:

1. Previous cancer diagnosis, except those patients who had a localized malignant tumour and who are five years cancer-free, as well as subjects with a history of skin cancers (of non-melanoma type) or excised in situ carcinomas.

2. Medical histories, be they psychiatric or of any other character, which, according to the judgement of the investigator, might interfere with the subject's granting of informed consent or the safe execution of the procedures required in the study.